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H ICON 


URGENT: FIELD SAFETY NOTICE 

ETHICON PHYSIOMESH™ Flexible Composite Mesh 
(All Product Codes) 


25 May 2016 

Dear Operating Room Supervisors, Materials Management Personnel, and Chief of Surgery: 

PLEASE DISTRIBUTE THIS INFORMATION TO ALL STAFF WITHIN YOUR FACILITY WHO USE 
ETHICON PHYSIOMESH™ FLEXIBLE COMPOSITE MESH 

At Ethicon, our first priority is to our customers and their patients, and that includes the safe and 
effective use of our products. 

Ethicon has initiated a voluntary product recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 
(for laparoscopic use) (“ETHICON PHYSIOMESH™ Composite Mesh”). Ethicon is recalling the product 
following an analysis conducted at the request of the Ethicon Medical Safety Team of unpublished data 
from two (2) large independent hernia registries (Herniamed German Registry and Danish Hernia 
Database- DHDB). The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia 
repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the 
comparator set of meshes among patients in these registries. 

Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue 
(including possible product characteristics, operative and patient factors), but has not been able to fully 
characterize these factors. Consequently, Ethicon have not been able at this time to issue further 
instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall 
ETHICON PHYSIOMESH™ Composite Mesh from the global market. 

Health care practitioners that have treated patients using ETHICON PHYSIOMESH™ Composite Mesh 
should continue to follow those patients in the usual manner. 

This voluntary recall has been communicated to the U.S. Food and Drug Administration (FDA) and the 
European Competent Authorities. 

This action involves only the ETHICON PHYSIOMESH™ Composite Mesh product line. It does not 
include the ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device, or other hernia mesh 
or device products manufactured or sold by Ethicon. 

The scope of this action includes all unexpired product codes of ETHICON PHYSIOMESH™ 
Composite Mesh and all unexpired Procedure Packs containing this product. 


Voluntary Product Recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 


Page 1 of 11 


URGENT: FIELD SAFETY NOTICE 

ETHICON PHYSIOMESH ™ Flexible Composite Mesh 
(All Product Codes) 

EFFECTIVE IMMEDIATELY - DO NOT USE OR DISTRIBUTE ANY OF THE FOLLOWING 
PRODUCT CODES: 


PRODUCT NAME 

PRODUCT CODE 

DESCRIPTION/SIZE 

PRODUCT LOT 

ETHICON 

PHYSIOMESH™ 

Flexible Composite 

Mesh 

PHY0715R 

Rectangle 

7.5cm x 15cm 

All unexpired lots 
impacted by this 
voluntary product 
recall. 

ETHICON 

PHYSIOMESH™ 

Flexible Composite 

Mesh 

PHY1015V 

Oval 

10cm x 15cm 

All unexpired lots 
impacted by this 
voluntary product 
recall. 

ETHICON 

PHYSIOMESH™ 

Flexible Composite 

Mesh 

PHY1515Q 

Square 

15cm x 15cm 

All unexpired lots 
impacted by this 
voluntary product 
recall. 

ETHICON 

PHYSIOMESH™ 

Flexible Composite 

Mesh 

PHY1520R 

Rectangle 

15cm x 20cm 

All unexpired lots 
impacted by this 
voluntary product 
recall. 

ETHICON 

PHYSIOMESH™ 

Flexible Composite 

Mesh 

PHY1520V 

Oval 

15cm x 20 cm 

All unexpired lots 
impacted by this 
voluntary product 
recall. 

ETHICON 

PHYSIOMESH™ 

Flexible Composite 

Mesh 

PHY2025V 

Oval 

20cm x 25cm 

All unexpired lots 
impacted by this 
voluntary product 
recall. 

ETHICON 

PHYSIOMESH™ 

Flexible Composite 

Mesh 

PHY2030R 

Rectangle 

20cm x 30cm 

All unexpired lots 
impacted by this 
voluntary product 
recall. 

ETHICON 

PHYSIOMESH™ 

Flexible Composite 

Mesh 

PHY2535V 

Oval 

25cm x 35cm 

All unexpired lots 
impacted by this 
voluntary product 
recall. 

ETHICON 

PHYSIOMESH™ 

Flexible Composite 

Mesh 

PHY3035R 

Rectangle 

30cm x 35cm 

All unexpired lots 
impacted by this 
voluntary product 
recall. 

ETHICON 

PHYSIOMESH™ 

Flexible Composite 

Mesh 

PHY3050R 

Rectangle 

30cm x 50cm 

All unexpired lots 
impacted by this 
voluntary product 
recall. 


Voluntary Product Recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 


Page 2 of 11 


URGENT: FIELD SAFETY NOTICE 

ETHICON PHYSIOMESH ™ Flexible Composite Mesh 
(All Product Codes) 

EFFECTIVE IMMEDIATELY - DO NOT USE OR DISTRIBUTE ANY OF THE FOLLOWING 
PROCEDURE PACKS: 


PRODUCT NAME 

PROCEDURE 

PACK PRODUCT 
CODE 

ETHICON 

PHYSIOMESH MESH 
PRODUCT CODE 

PRODUCT LOT 

Laparoscopic Hernia 

Pack 

ELH5 

PHY1515Q 

All unexpired lots 
impacted by this 
voluntary product 
recall. 

Laparoscopic Hernia 

Pack 

ELH10 

PHY1515Q 

All unexpired lots 
impacted by this 
voluntary product 
recall. 


IDENTIFICATION OF PRODUCT SUBJECT TO THIS ACTION: 

Product subject to the voluntary product recall in your inventory can be identified by product 
code (see product code listing above). All unexpired, unused ETHICON PHYSIOMESH™ 
Composite Mesh products are subject to this action and are required to be returned. The 
product code can be determined by using the Product Identification Tools attached at 
Attachment 1 (individual product codes) and Attachment 2 (Procedure Packs). 

ACTION REQUIRED: 

1. Examine your inventory immediately to determine if you have product subject to this action on 
hand and quarantine such product(s). 

2. Remove the product subject to this voluntary product recall and communicate the issue to 
relevant operating room or materials management personnel, or anyone else in your facility who 
needs to be informed. 

3. If any product subject to this action has been forwarded to another facility, contact that facility to 
arrange return. 

4. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and 
provide a copy to [INSERT LOCAL AFFILIATE OR SALES REPRESENTATIVE, EMAIL 
ADDRESS, FAX NUMBER] within three (3) business days. Please return the BRF even if you 
do not have product subject to this action. 

5. Keep this notice visibly posted for awareness until all product subject to this recall has been 
returned to Ethicon. While processing your returns, please maintain a copy of this notice with 
the product subject to this action and keep a copy for your records. 

6. Customers are required to return all unexpired ETHICON PHYSIOMESH™ Composite Mesh 
products that are in their inventory immediately. Only unexpired product subject to this recall 
returned by September 16, 2016 will be credited to your account. Expired product that is 
returned after that date will not be reimbursed. 


Voluntary Product Recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 


Page 3 of 11 


URGENT: FIELD SAFETY NOTICE 

ETHICON PHYSIOMESH ™ Flexible Composite Mesh 
(All Product Codes) 

7. To return product subject to this action, photocopy the completed BRF, place it in the box with 
the product, and return the product to your Sales Representative. 

Ethicon will not return the ETHICON PHYSIOMESH™ Composite Mesh product to the market 
worldwide. 

Ethicon recognizes the voluntary product recall of the ETHICON PHYSIOMESH™ Composite Mesh 
may be disruptive to your facility and apologizes for any inconvenience this may cause. 

Ethicon offers the following products to consider for ventral hernia repair and other fascial deficiencies. 

For intraperitoneal/intra-abdominal mesh placement: 

• PROCEED™ Surgical Mesh 

• ETHICON PHYSIOMESH™ Open 

For extraperitoneal mesh placement, Ethicon manufactures several flat meshes for use in 
extraperitoneal ventral hernia repair: 

• PROLENE™ Mesh 

• PROLENE™ Soft Mesh 

• ULTRAPRO™ Mesh 

• ULTRAPRO™ Advanced Mesh 

Please read the full Instructions for Use for the above named products for more detailed information on 
proper use, indications, contraindications, warnings, precautions and adverse events. Please also 
consider alternative products from other manufacturers and alternative procedures to treat patients with 
hernias. 

If you require assistance with alternative options for hernia repair, please contact your Sales 
Representative. 

As with any medical device, adverse reactions or quality problems experienced with the use of this 
product should be reported your Sales Representative, directly to Ethicon, or to your National Health 
Authority. 

If you have any further questions related to this notice or if you require additional information, please 
contact your Sales Representative. 

Attachments: 

Attachment 1: Product Identification Tool 
Attachment 2: Procedure Pack Identification Tool 
Attachment 3: Business Reply Form 


Voluntary Product Recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 


Page 4 of 11 


URGENT: FIELD SAFETY NOTICE 

ETHICON PHYSIOMESH ™ Flexible Composite Mesh 
(All Product Codes) 

ATTACHMENT 1: Product Identification Tool for ETHICON 
PHYSIOMESH™ Flexible Composite Mesh (All Product Codes) 

This tool will help customers identify the lots of product subject to this action by using the 
package labels. This document applies to the Tyvek® envelope and foil pouch for the product 
codes identified on page 2 of the Field Safety Notice. 

Product Code PHY3050R is used as an example. 


TYVEK® ENVELOPE (containing 1 mesh) 

Front of Envelope 



Voluntary Product Recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 


Page 5 of 11 


URGENT: FIELD SAFETY NOTICE 

ETHICON PHYSIOMESH ™ Flexible Composite Mesh 
(All Product Codes) 


FOIL POUCH (containing 1 mesh) 

Front of Pouch 



ETHICON 


PHY305DR 


PHYSIOMESH 

Flexible Composite Mesh 


Flexibele samengestelde mesh 
Treillis flexible composite 
Flexibles Korn posit- Netz 
Rete composite flessibile 
Rede Composts Flexlvel 
Mai I a compuesta flexible 


□ 'Tl SselidructHis /X\ Do lot 

l] For Use Reuse 


Mate in Germany 

Made byJohnson £ Jotinson UDIUL GmbH 
Distributed in the US by ETHIOOH, Inc 
Swnervile, HJ OttK-0151 
OEthioon, Inc 3013 KJM& 


30 cm x 50 cm 

(1 2 in x 20 in) 

1 Piece 
1 stuk/ 1 article 
1 Stuck / 1 pezzo 
1 pe<;a / 1 unidad 


2D 

Barcode 

placement 


ISTEMLE. |E0| Utility 

C 6 0086 

[lot] BATCH 
2 YYYY 


Johnson ^Johnson International 
dh European LogbfcCenliie 
Leonado Da Vi ndlaan, IE 
BE-lffil Bqem 
Bdgiim 


US Patent(s) 7,615,045 


S BATCH 
2 YYYY-MM - 





Voluntary Product Recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 


Page 6 of 11 


URGENT: FIELD SAFETY NOTICE 

ETHICON PHYSIOMESH ™ Flexible Composite Mesh 
(All Product Codes) 

Back of Pouch 



Product Traceability Label 

30x50cm PHY30 
ETHICON 
PHYSIOMESH™ 

I lot I BATCH 
£ YYYY-MM 
KTI I I CON® 

Product Traceability Label 

30x50cm PHY30 
ETHICON 
PHYSIOMESH™ IRT'5 

I lot | BATCH 
g YYYY-MM 

ETI II CO N® 


Product Traceability Lai 

30x50cm PHY30 
ETHICON I ly/z 

PHYSIOMESH™ liTC 

| lot | BATCH 

£ YYYY-MM 

E 7 H ICON® 

Product Traceability Lai 

30x50cm PHY30 
ETHICON 
PHYSIOMESH™ 
lot | BATCH 
£ YYYY-MM 
h I M ICON® 



Voluntary Product Recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 


Page 7 of 11 


URGENT: FIELD SAFETY NOTICE 

ETHICON PHYSIOMESH ™ Flexible Composite Mesh 
(All Product Codes) 

ATTACHMENT 2: Product Identification Tool for Procedure Packs 
Containing ETHICON PHYSIOMESH™ Flexible Composite Mesh 
(Product Codes: ELH5 and ELH10) 

This tool will help customers identify the Procedure Packs containing product subject to this 
action by using the package labels. This document applies to the labeling on Procedure Pack 
Product Codes ELH5 and ELH10 as identified on page 2 of the Field Safety Notice. 

Product Code ELH5 is used as an example. 


Procedure Pack Top Label 



Qty 


1 


Product 

Code 


2B12LT 


Product Description 



Consult Instuctiorrs For Use 


ENDOPATH© XCEL™ with OPT I VIEW™ Technology Bladelm Trocar with Stability Sleeve 
- 12 nun Diameter, 1Q0 mm Shaft Length 


C € 0125 



ENDOPATH'E 1 XCEL™ avec technology OFTIVIEW™ Trocart sana lame avec chemlae atriee 
- 12 mm da dlametra,tlgeda 100 mm de long 

ENDOPATH'E 1 XCEL™ mlt onwiEW 1H Technology BladeleaaTnoKarohne Kllnge mlt proflllarterHLilaa 

- Durchmeaaer 12 mm, Schaftiange von 100 mm 

Trocar aenza lama ENDORATHS 1 XCEL 1U con teen ologla OPTI VIEW" 1 con cannula dl atablllta 

- dlam etro 1 2 mm, I u ng hezza atelo d 1 100 mm 

Trocart e aem Lamina com canula de Establl Iza^ao ENDOPATHE'XCEL™ com tacnologla OPTIVIEW™ 

- diametro de 12 mm, ha ate de 100 mm de comprlmento 

linear aln hoja con canula de eetabllldad ENDOFATHE-XCEL™ con tacnologla QFTIVIEW™, 

- 12 mm de diametro, eje de 100 mm de longltud 


ENDOPATH'E XCEL™ metOFTWIEW™ Technology Lemmetloze trocar met atablllteltahula, 
- 12 mm diameter, Schachtlangte van 100 mm 


B5LT 

C t 0123 



END0PATH®XCEL™ Bladalass Trocar with Stability Slewe. 5 mm diameter - 10Q mm Isiigdi 

Ttocart aana lame ENDOPATHS'XCEL™ avec. chemise de Btablllta,E mm de dlametre - 100 mm de long 
ENDOPATH'E 1 XCEL™ Bladelaaa Trokarohna Kllnge mlt proflllarterHLilaa, E mm Durchmeaser- 100 mm Lange 
ENDOPATH'E 1 XCEL™ Trocar aenza lama con cannula dl stability. diametro E mm - lunghezza 100 mm 
ENDOPATH'E* XCEL™ TTocarta sem Lamina com canula de Eatablllzagao, E mm da diametro - 100 mm de comprlmento 
ENDOPATH'E 1 XCEL™ Trocar aln hoja con canula de eatablllda(l. E mm de diametro - 100 mm de longltud 
ENDOPATH'E- XCEL™ L emmet] oze trocar met atablllteltBhula r E mm diameter- 100mm lengte 


1 


1 


CB5LT 

C € 0123 



ENBOfiATH® XCEL™ Universal Trocar Stability Sle e ve - 5 mm Diamorer, 100 mm Loiglh 

Chemlae atriee unlveraelle pour trocart ENDORATHS' XCEL 1U - E mm de diameter, 100 mm de long 
ENDOPATH’E- XCEL™ protlllerte Unlveraal-TrokartiLilae - E mm Durchmeaaer, 100 mm Umge 
Cannula dl stability unlveraale per trocar ENDOPATH'E- XCEL™ - diametro E mm, lunghena 100 mm 
canula unlveraal da eatablllzagao dotrocarta ENDORATH€' XCEL 1U - E mm de diametro, 100 mm de comprlmento 
canula unlveraal de eatablllzaclOn dal trocar ENDOFATM'E-XCEL™ - Emm dedldmetro, 100 mm de longltud 
ENDOPATH'E 1 XCEL™ Unlveraale trocaratablllteltahuls - diameter Emm, lengte 100 mm 


STRAP25R 

C d 00® 



ETHICON SECUfiESTRAP™ AbswbaUe Snap Fixali on Davie# 

DlapoattlT deflation Strap resorbable de ETHICON SECURESTRAP™ 

ETHICON SECURESTRAP™ Flxlerungsl nstrument tUr resorblerba re Straps 
Dlspoaltlvo dl Useagglo dl gratia asaorblblll da ETHICON SECU RESTR AP™ 
Dlspcaftlvo detha^ao STRAP abaorvfvel de ETHICON SECURESTRAP™ 
Dlspoaltlvo deflJaclOn de anclaje abaorblble de ETHICON SECURESTUAP™ 
ETHICON SECURESTRAP 111 Inatmment met bred e resorbeerbareflKatlebandJea 



PHYSIOMESH™ 
Product Code 


ETHICON PHYSIOMESH™ Ftexitk) Comp Mile Mesh 15x15 cm 

ETHICON PHYSIOMESH'- ITellll a flexible composite IEkIE cm 
ETHICON PHYSIOMESH™ Rexlblea Kompoalt-Netz lEfclEcm 
ETHICON PHYSIOMESH™ Rete composlta tleaalblle lEalEcm 
ETHICON PHYSIOMESH™ Rede Compoata RaafVal lExlE cm 
ETHICON PHYSIOMESH™ Malla compueata flexible lExlEcm 
ETHICON PHYSIOMESH™ Rexlbele ssmengesteldemeah lEfclEcm 


Voluntary Product Recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 


Page 8 of 11 


URGENT: FIELD SAFETY NOTICE 

ETHICON PHYSIOMESH ™ Flexible Composite Mesh 
(All Product Codes) 


Procedure Pack Side Label 



Voluntary Product Recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 


Page 9 of 11 


FriKHiH? dirjnkm >tu ia iim 

NODI H13 



URGENT: FIELD SAFETY NOTICE 

ETHICON PHYSIOMESH ™ Flexible Composite Mesh 
(All Product Codes) 

ATTACHMENT 3: Business Reply Form (BRF) 

Your timely response to this customer notification is requested. Please complete and fax/email this form 
to [INSERT LOCAL AFFILIATE NAME, EMAIL ADDRESS, FAX NUMBER] within 3 business days, 
even if you do not have product subject to this voluntary product recall to return. 

If you have product subject to this recall to return, please make a photocopy of your completed Business 
Reply Form and enclose with your return. Thank you for your cooperation. 

Product Inventory - please check TWO 

D We have no ETHICON PHYSIOMESH™ Flexible Composite Mesh subject to this action. 

□ We have no Procedure Packs subject to this action. 

G We have Procedure Packs subject to this action and are returning the following devices: 

D We have ETHICON PHYSIOMESH™ Flexible Composite Mesh subject to this action and are 
returning the following devices: 


Device Name 

Product 

Code 

Quantity Returning 
(in “Eaches”) 

Product 

Code 

Quantity Returning 
(in “Eaches”) 

ETHICON 

PHYSIOMESH™ 

Flexible 

Composite 

Mesh 

PHY0715R 


PHY2025V 


PHY1015V 


PHY2030R 


PHY1515Q 


PHY2535V 


PHY1520R 


PHY3035R 


PHY1520V 


PHY3050R 



Procedure Pack 
Name 

Procedure Pack 
Product Code 

Device 

Product Code 

Quantity Returning 
(in “Eaches”) 

Laparoscopic 
Hernia Pack 

ELH5 

PHY1515Q 


ELH10 

PHY1515Q 



Facility Name: 


Street Address: 


City, Country, Postal Code: 


Voluntary Product Recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 


Page 10 of 11 


URGENT: FIELD SAFETY NOTICE 

ETHICON PHYSIOMESH ™ Flexible Composite Mesh 
(All Product Codes) 


Print Name of Person Completing Business Reply Form: 

Telephone Number: 

Account Number: 

(number used to order J&J product) 

Date: 

Signed*: 


*Your signature provides confirmation that you have received and understood this notification 


Your comments are welcome. 


Voluntary Product Recall of ETHICON PHYSIOMESH™ Flexible Composite Mesh 


Page 11 of 11